[Federal Register Volume 86, Number 204 (Tuesday, October 26, 2021)]
[Notices]
[Pages 59190-59196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23263]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 20-22]


Nicholas P. Roussis, M.D.; Decision and Order

    On May 27, 2020, the Assistant Administrator, Diversion Control 
Division, Drug Enforcement Administration (hereinafter, DEA or 
Government), issued an Order to Show Cause to Nicholas P. Roussis, M.D. 
(hereinafter, Respondent), of Staten Island, New York. Order to Show 
Cause (hereinafter, OSC), at 1. The OSC proposed the denial of 
Respondent's application for DEA Certificate of Registration, Control 
No. W19115227C, because Respondent was mandatorily excluded from 
```participation in Medicare, Medicaid, and all federal health care 
programs for a minimum period of 10 years' pursuant to 42 U.S.C. 1320a-
7(a)'' and such exclusion ``warrants denial of [Respondent's] 
application for a [registration] pursuant to 21 U.S.C. 824(a)(5).'' Id. 
at 1-2 (citing Richard Hauser, M.D., 83 FR 26308 (2018)).
    Specifically, the OSC alleged that, on October 16, 2017, the United 
States District Court for the District of New Jersey issued a judgment 
against Respondent ``based on [Respondent's] plea of guilty to the 
charge of Racketeering-Transporting in Aid of Travel Act-Acceptance of 
Bribes, in violation of 18 U.S.C. 1952(a)(3) & 18 U.S.C. 2, a felony.'' 
Id. at 2 (citing U.S. v. Nicholas P. Roussis, No. 2:17-cr-00231-SRC 
(D.N.J.)). The OSC further alleged that ``[b]ased on [Respondent's] 
conviction, the U.S. Department of Health and Human Services, Office of 
the Inspector General (``HHS/OIG''), by letter dated April 30, 2018, 
mandatorily excluded [Respondent] from `participation in Medicare, 
Medicaid, and all federal health care programs for a minimum period of 
10 years' pursuant to 42 U.S.C. 1320a-7(a), effective May 20, 2018.'' 
Id.
    The OSC notified Respondent of the right to request a hearing on 
the allegations or to submit a written statement, while waiving the 
right to a hearing, the procedures for electing each option, and the 
consequences for failing to elect either option. Id. at 3 (citing 21 
CFR 1301.43). The OSC also notified Respondent of the opportunity to 
submit a corrective action plan. Id. at 3-4 (citing 21 U.S.C. 
824(c)(2)(C)).
    By letter dated June 30, 2020, Respondent timely requested a 
hearing. Administrative Law Judge Exhibit (hereinafter, ALJX) 2. The 
matter was placed on the docket of the Office of Administrative Law 
Judges and was assigned to Administrative Law Judge Mark M. Dowd 
(hereinafter, the ALJ). On July 1, 2020, the ALJ issued an Order for 
Prehearing Statements. ALJX 3. The Government timely filed its 
prehearing statement (hereinafter, Govt Prehearing) on July 13, 2020. 
ALJX 4. Respondent timely filed his prehearing statement (hereinafter, 
Resp Prehearing) on July 22, 2020. ALJX 5. On July 28, 2020, the ALJ 
issued a prehearing ruling that, among other things, established the 
schedules and procedures for the remaining prehearing activities and 
for the hearing. ALJX 6 (Prehearing Ruling, at 1-11).
    On September 8, 2020, the Government filed ``Objections Pursuant to 
21 CFR 1316.59'' (hereinafter, Govt Objections), which objected to the 
admission of certain evidence submitted by Respondent on the grounds of 
authenticity. ALJX 8 (Govt Objections), at 2. The evidence in question 
consisted of ``Respondent's Exhibit 1, a 38-page document containing 
approximately 18 letters'' that Respondent had submitted on August 3, 
2020. Govt Objections, at 1. According to the Govt Objections, ``[m]ost 
of the letters [appeared] to have been drafted . . . nearly three years 
before the Government served its [OSC].'' Id. Further, the Government 
alleged that, ``[a]ll but two of the letters [were] unsigned and four 
[were] undated.'' Id. Finally, the Government claimed that, 
``[although] all but one of the letters [appeared] to be directed 
toward a Federal District Court Judge in connection with U.S. v. 
Nicholas P. Roussis . . . the letters [did] not seem to be available 
for inspection as part of the publically [sic] assessable electronic 
court file.'' Id. at 2. The Government concluded that because ``all but 
two of the letters [were] unsworn and no witness [was] disclosed to 
authenticate and/or lay a foundation for the documents' admissibility'' 
the letters should not be admitted. Id. On September 9, 2020, 
Respondent filed a Reply to Government's Objections (hereinafter, Reply 
to Objections). In the Reply to Objections, Respondent attached an 
affirmation from one of the attorneys who represented him in his 
criminal case. Reply to Objections, at 1. The affirmation stated that 
all 18 letters had been submitted as exhibits to the District of New 
Jersey as part of Respondent's sentencing submission during his 
criminal case. Reply to Objections, Attachment (Affirmation of Angela 
D. Lipsman), at 1-3. In the Reply to Objections, Respondent stated, 
``[p]lease consider that affirmation as a response to the Government's 
objections.'' Reply to Objections, at 1. At the hearing in this matter, 
which took place on September 14, 2020, the Government further objected 
to the admission of the letters on the grounds of relevance. Tr. 41. 
The Government argued that in context, the letters related only to the 
sentencing of the Respondent in his criminal case and not to 
Respondent's prescribing practices or whether he could be entrusted 
with a DEA registration. Tr. 41-42. The ALJ ultimately overruled the 
Government's objections on both grounds of authenticity and relevance 
and admitted the letters into the record. Tr. 42-43.
    The hearing in this matter took place via video teleconference on 
September 14, 2020. Following the hearing, both the Government and the 
Respondent filed their post-hearing briefs on October 21, 2020. On 
November 5, 2020, the ALJ issued the Recommended Rulings, Findings of 
Fact, Conclusions of Law, and Decision (hereinafter, RD). Neither party 
filed exceptions to the RD. See generally Transmittal Letter. I have 
reviewed and agree with the procedural rulings of the ALJ during the 
administration of the hearing.
    Having considered the record in its entirety, I agree with the ALJ 
and find that that the record established by substantial evidence a 
prima facie case supporting the denial of Respondent's application. RD, 
at 37. I also agree with the ALJ that the Respondent failed to fully 
accept responsibility for his misconduct, failed to demonstrate that 
the Agency can entrust him to maintain his registration, and therefore, 
that denial of his application is the appropriate sanction. Id. I make 
the following findings of fact.

[[Page 59191]]

I. Findings of Fact

A. Respondent's Application for DEA Registration

    Respondent previously held DEA registration No. BR8697940 as a 
practitioner authorized to handle controlled substances in Schedules 
II-V at the registered location of 2627B Hylan Blvd., Staten Island, NY 
10306. RD, at 11 (Stipulation 1). Respondent's previous DEA 
registration expired by its terms on April 30, 2019. Id. On October 4, 
2019, Respondent applied for a DEA registration, which was assigned 
Control No. W19115227C, in Schedules II-V at 4735 Hylan Blvd., Staten 
Island, New York 10312. GX 1, at 1; see also RD, at 12-13 (Stipulation 
8).\1\
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    \1\ The parties stipulated that the application was submitted on 
October 7, 2019, based on the Government's prehearing statement, but 
it appears that the application submission date was a scrivener's 
error.
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B. Respondent's Criminal Conviction

    The evidence in the record demonstrates that on June 21, 2017, an 
Information was filed in the United States District Court for the 
District of New Jersey against Respondent. GX 3; RD, at 13. The 
Information charged that from October 2010 through April 2013, 
Respondent engaged in commercial bribery in violation of N.J.S.A. Sec.  
2C:21-10, 18 U.S.C. 1952(a)(3). Id. at 4. The Information charged that 
from October 2010 through April 2013, Biodiagnostic Laboratory 
Services, LLC (hereinafter, BLS), a clinical blood laboratory, paid 
Respondent and his brother bribes of approximately $175,000 in the 
aggregate to refer patient blood specimens to BLS. Id. at 1, 4-5; see 
also RD, at 12 (Stipulations 3-4). The Information charged that BLS 
used the patient blood specimens from Respondent to submit claims to 
Medicare, Tricare, and private insurers to collect approximately 
$250,000. Id. at 5. Further, the Information charged that between 
October 2010 and April 2013, ``in addition to cash payments'' BLS paid 
bribes to Respondent and his brother in the form of trips to strip 
clubs where ``BLS paid for women to perform lap dances on, and engage 
in sex acts with [Respondent] and [Respondent's brother].'' Id.; see 
also RD, at 12 (Stipulation 4). On June 21, 2017, Respondent pled 
guilty to the charge of Racketeering-Transporting in Aid of Travel Act-
Acceptance of Bribes in violation of 18 U.S.C. 1952(a)(3) & 18 U.S.C. 
2. GX 4, at 3. Respondent was found guilty on October 16, 2017. GX 4, 
at 3; see also RD, at 12 (Stipulation 2). Respondent was sentenced to 
serve 24 months in prison, pay a fine of $5,000, and forfeit $175,000. 
GX 3, at 7; GX 4, at 4, 8, and 9; see also RD, at 12 (Stipulation 5).

C. Respondent's Exclusion

    Based on Respondent's conviction, on April 30, 2018, HHS/OIG 
excluded Respondent from participation in Medicare, Medicaid, and all 
federal health care programs for a minimum period of 10 years pursuant 
to 42 U.S.C. 1320a-7(a). GX 2, at 1; see also RD, at 12 (Stipulation 
6).

D. Respondent's State Medical License

    Respondent was authorized to practice medicine in the State of New 
York by issuance of license number 231555. GX 7, at 1. Following 
Respondent's guilty plea and conviction, Respondent's New York medical 
license was suspended during the period of his incarceration after a 
charge of professional misconduct was sustained. Id. Respondent's state 
medical license was to be reinstated on August 16, 2019, subject to 
probation for five years and other conditions. Id. According to the 
State of New York's online records, the status of Respondent's state 
medical license is currently listed as ``Registered.'' http://www.op.nysed.gov/opsearches.htm (last visited date of signature of this 
Order). Following his conviction, Respondent was also excluded from 
participation in the New York State Medicaid program, effective August 
30, 2017. GX 5; see also RD, at 12 (Stipulation 7).

E. The Parties' Positions

1. Government's Position
    The OSC's sole allegation is that Respondent's exclusion from 
federal health care programs pursuant to 42 U.S.C. 1320a -7(a) warrants 
denying his application under 21 U.S.C. 824(a)(5). OSC, at 2; Govt 
Prehearing. The Government alleges that Respondent's exclusion was 
based on his guilty plea to the charge of Racketeering-Transporting in 
Aid of Travel Act-Acceptance of Bribes, in violation of 18 U.S.C. 
1952(a)(3) & 18 U.S.C. 2. Id. The Government further alleges that 
Respondent's exclusion from Medicare, Medicaid, and all federal health 
care programs warrants denial of his application notwithstanding the 
fact that the underlying conduct that led to his exclusion did not have 
a nexus to controlled substances. Id.
    The Government's documentary evidence includes a copy of 
Respondent's application for DEA registration No. W19115227C as well as 
a copy of Respondent's exclusion letter from HHS/OIG. See GX 1 and 2. 
The Government's documentary evidence also includes a copy of the 
Information filed in the United States District Court for the District 
of New Jersey against Respondent and the Terms of Probation and Order 
of Judgment following Respondent's conviction. See GX 3 and 4. Finally, 
the Government's documentary evidence includes various New York State 
documents pertaining to Respondent's exclusion from the New York State 
Medicaid program, the status of Respondent's New York State medical 
license, and Respondent's disciplinary proceedings with the New York 
State Department of Health following his conviction. See GX 5-7.
    The Government called one witness to testify at the hearing, a 
Group Supervisor (hereinafter, GS) who works for the DEA New York Field 
Division. The GS testified about her investigation-related actions, 
including obtaining the Government's documentary evidence and 
confirming that Respondent's exclusion from federal health care 
programs was still in effect. Tr. 16-30; see also RD, at 5-6. The GS 
also authenticated the Government's documentary evidence through her 
testimony. Id.
    Having read and analyzed all of the record evidence, I agree with 
the RD that the GS was ``consistent, genuine and credible,'' in her 
testimony and that the GS ``effectively explained how the investigation 
of the Respondent began and how she verified the Respondent's exclusion 
from federal [health care] programs.'' RD, at 22. I also agree with the 
RD that although she was the Government's witness, there was ``no 
indication from her testimony that any partiality interfered with her 
reliable testimony.'' Id.
2. Respondent's Position
    Respondent requested a hearing in response to the Government's OSC, 
asserting that although his medical license had been restored, without 
a DEA registration, he was not able to effectively practice. Request 
for a Hearing (hereinafter, Hearing Request).
    The Respondent's documentary evidence includes a collection of 
support letters from patients, colleagues, family, and friends that had 
been previously submitted to the District of New Jersey as part of 
Respondent's sentencing submission during his criminal case. See RX 1. 
Respondent was the sole witness to testify for his case.
    Respondent testified that he has a wife, three children, and an 
elderly mother with medical problems who lives with him and his family. 
Tr. 31-32. Respondent became involved with

[[Page 59192]]

BLS when a friend, who was a pharmaceutical representative for another 
company, started working for BLS as a salesman. Id. at 53. Respondent's 
friend asked him if he would ``send business his way'' just as he was 
sending it to other laboratories. Id. at 54. Respondent was ``very 
financially pressed'' at the time and when his friend and BLS offered 
to help him with some of his bills, ``at that point, [he] accepted.'' 
Id. Respondent and his co-defendant, his brother, received a combined 
$175,000 from BLS. Id. at 60-61. The bribes were periodic monthly 
payments of approximately $2,000 to $3,000 and not based on specific 
referrals. Id. at 69-70. BLS also paid for Respondent and his brother 
to go to strip clubs and to receive lap dances. Id. at 61-62. 
Respondent received payments from approximately October or November 
2010 until January or February 2013. Id. at 70-71.
    Respondent testified that he never prescribed any medication that 
was not necessary, never performed any unnecessary tests, and was never 
charged with performing any unnecessary tests. Id. at 32-33. Further, 
he claimed that the Government did not lose any money because 
Respondent used BLS and the payments made to BLS were the same as would 
be made to any other laboratory. Id. at 33-34. Additionally, Respondent 
testified that BLS was a ``credible laboratory'' \2\ that provided 
legitimate, accurate, and verified \3\ results and never did any 
improper testing. Id. at 33. He stated that BLS results were 
consistent, BLS was faster than other laboratories, and BLS never 
charged the patients any copay. Id. at 54-55; see also id. at 33 
(``their turnaround time was quicker than the other laboratories, which 
was also another reason why I used them, as well.''). Respondent 
testified that ``from a testing aspect and a laboratory aspect'' he was 
satisfied with BLS. Id. at 55. Respondent testified that ``no patients 
were harmed in any way'' and that his actions did not cost the patients 
any money. Id. at 59. Nonetheless, Respondent testified that his 
actions were not a victimless crime and that his patients were the 
victims. Id. at 60. Respondent admitted to pleading guilty to the 
charges against him and when prompted for an explanation, said he did 
not have an explanation for it. Id. at 32. Respondent stated, ``It was 
the wrong thing to do, it was a wrong decision on my part, and I regret 
it every day, to this day.'' Id.
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    \2\ When prompted later during cross examination, Respondent 
clarified that he had meant that BLS was a ``credible'' laboratory 
in terms of their work, not in terms of their behavior. Id. at 53-
55.
    \3\ Respondent initially testified that he had verified all of 
the results from all of the patients that he sent to BLS, 
approximately 500 patients. Id. at 55-56. When prompted for 
clarification, however, Respondent admitted that he did not actually 
verify every single patient that he had sent to BLS. Id. at 56-57.
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    Respondent was incarcerated and his medical license was suspended 
while he was incarcerated. Id. at 34. Respondent's medical license has 
since been restored subject to probation with a practice monitor for 
two years. Id. at 32. Respondent testified that even though his medical 
license was restored, without a DEA license, he cannot effectively 
practice. Id. at 48. Respondent testified that he was ``totally 
guilty'' and ``totally [took] responsibility for what [he] did.'' Id. 
Respondent testified that he made a very bad decision that negatively 
affected his life as well as his family and patients. Id. at 48-49. 
There was a hearing regarding Respondent's medical license and the 
hearing committee determined that Respondent's medical license should 
be suspended, not revoked. Id. at 34-37. The hearing committee made 
their recommendation based on Respondent's acknowledgement of his poor 
judgment, Respondent's personal statement expressing remorse, the 
testimony of other doctors, letters from patients, and Respondent's 
remedial efforts in lecturing about his misconduct. Id. at 37-38. 
Respondent also wrote a letter to the Department of Health and Human 
Services ``trying to find out, and to speak with the judge . . . as to 
why [he] would have a ten year exclusion being the fact that [his 
actions were] nothing having to do with [billing].'' Id. at 51. 
Respondent testified that he ``had no part of the billing at all with 
Medicare and Medicaid, or the TRICARE federal services'' and ``[a]ll 
[he] did was [he] accepted the bribes.'' Id. Respondent also requested 
if he could have a decrease in his mandatory restriction, but the ten-
year restriction was upheld. Id. at 51-52.
    Respondent testified that he suffered in prison because he was away 
from his family. Id. at 49. While he was in prison, he ``tried to stay 
proactive'' and read medical journals. Id. Since his release from 
prison, he has taken over 200 hours \4\ in continuing medical education 
courses (CME), multiple courses and certifications in his field, 
medical ethics courses, and courses such as the DEA's opioid training 
program. Id. at 38-39. Respondent also mentioned that he had become a 
CPR instructor and performed CPR classes. Id. at 39. Respondent also 
spoke to the Medical Society of Staten Island and to the residents at 
Richmond University Medical Center to explain what he had done and to 
deter them from making the same mistake. Id. at 47. Respondent 
testified that he had destroyed his life, embarrassed himself and his 
family, and become an embarrassment to his patients, community and 
church. Id. He explained that he ``just became very proactive because 
[he] wanted [his] medical license.'' Id. Respondent testified that he 
paid back all his debts to society from his forfeiture, fines, prison, 
and supervised release. Id. at 50. Respondent testified that medicine 
is ``the only thing [he knows] how to do'' and ``the only thing [he 
wants] to do.'' Id. at 49. Respondent testified that he wants to get 
back to practicing medicine and become a good member of society again. 
Id. at 49-50.
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    \4\ Respondent initially testified that he had taken over 200 
``courses'' but later clarified that he had meant 200 hours of 
courses. Id. at 38, 64.
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    Respondent stated that while previously working in obstetrics and 
gynecology, he did not prescribe oxycodone or opioids to patients and 
the most he ever prescribed was Tylenol with Codeine after delivery or 
a caesarian section.\5\ Id. at 64. Respondent testified that he ``never 
really prescribed any controlled substances unless [he] had to.'' Id. 
Respondent currently has an aesthetics practice where ``[he] will be 
doing injectables, fillers, hormone therapy, and weight loss 
treatment'' and that it is the type of practice he intends to maintain. 
Id. at 52. Respondent testified that he would need Schedules II-V for 
his practice. Id. at 53. Finally, Respondent testified that the 
majority of the support letters that had been submitted during his 
criminal case had been sent directly to his attorney. Id. at 58-59. 
Respondent had spoken to patients and asked them if they would write 
character letters for him as well as provided his attorney's email for 
them to send the letters directly. Id. at 59.
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    \5\ This was the only testimony Respondent gave pertaining to 
his work in obstetrics and gynecology.
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    Having read and analyzed all of the record evidence, I agree with 
the RD that Respondent was candid in discussing the details of his 
misconduct as well as the remedial efforts that he made following his 
conviction. RD, at 22-23. However, I also agree with the RD that 
Respondent's conflicting statements, particularly those regarding his 
characterization of BLS as a ``credible'' laboratory and his initial 
claim that he had verified all of the results from BLS, as well as the 
defensive bend to much of his testimony, reduce his credibility and the

[[Page 59193]]

weight the decision gives to his testimony. Id. at 23-24; Tr. 33 and 
53-57.

II. Discussion

A. Government's Position

    In its Proposed Findings of Fact and Conclusions of Law 
(hereinafter, Government's Post-Hearing Brief), the Government argues 
that ``[m]andatory exclusion pursuant to 42 U.S.C. 1320a-7(a) is a 
basis to revoke a DEA registration under 21 U.S.C. 824(a)(5)'' and that 
``notwithstanding the fact that the underlying conduct for which 
Respondent was convicted had no nexus to controlled substances, 
Respondent's mandatory exclusion from Medicare, Medicaid and all 
Federal health care programs by HHS/OIG warrants revocation of his 
registration pursuant to 21 U.S.C. 824(a)(5).'' Government's Post-
Hearing Brief, at 9. Additionally, the Government argues that 
Respondent's continued registration would be contrary to the public 
interest, specifically under factor five of 21 U.S.C. 823(f), ``such 
other conduct which may threaten the public health and safety.'' Id. at 
10-11. Further, the Government argues that ``[Respondent's] crimes were 
not wholly unrelated to his practice as a practitioner'' and that 
``[his] behavior [evinced] a severe lack of ethical judgment that, had 
it occurred in a clinical context, could have resulted in diversion or 
an adverse impact on patient care.'' Id. Finally, the Government 
expresses doubts as to Respondent's acceptance of responsibility for 
his actions and emphasizes the deterrent effects of revoking 
Respondent's registration. Id. at 12-13.

B. Respondent's Position

    In Respondent's Post-Hearing Brief, Respondent highlighted the 
Determination and Order of the Hearing Committee on [New York State] 
Department of Health, State Board for Professional Medical Conduct 
(hereinafter, Hearing Board) that rejected revocation of Respondent's 
medical license and instead suspended Respondent's license. 
Respondent's Post-Hearing Brief, at 3. Respondent alleged that the 
Hearing Board based its judgment on ``Respondent's acknowledgement of 
his poor judgment in accepting bribes, his remorse for his criminal 
conduct, and the testimony of two doctors and patients' letters.'' Id. 
Respondent also highlighted how he had ``lectured to physician 
residents . . . about his misdeeds'' and that ``since [his] release 
from prison, [he had] taken over 200 hours of CME courses'' including 
DEA's opioid training program. Id. Further, Respondent argued that he 
was ``a true follower of the Hippocratic Oath'' and provided letters 
from patients, colleagues, family, and friends to ``[demonstrate] the 
type of care [he] provided to his patients and how they reflect his 
following the Hippocratic Oath.'' Id. at 3-4. In concluding his Post-
Hearing Brief, Respondent emphasized that he had broken the law, made a 
mistake, and ``paid dearly for it.'' Id. at 6. Respondent also 
reiterated that without a DEA license, he would no longer be able to 
practice medicine and earn a living as a doctor. Id.

C. Analysis of Respondent's Application for Registration

    In this matter, the OSC calls for my adjudication of the 
application for registration based on the charge that Respondent was 
excluded from participation in a program pursuant to section 1320a-7(a) 
of Title 42, which is a basis for revocation or suspension under 21 
U.S.C. 824(a)(2). OSC, at 1-2. The Government did not allege that 
Respondent's applications should be denied because his registration 
would be inconsistent with the public interest pursuant to section 823 
in the OSC and did not advance any arguments or present any evidence 
under the public interest factors in its prehearing statement. See 
generally Govt Prehearing; OSC. The Government raised the public 
interest factors in its Post-hearing Brief; however, I find that they 
are unavailable as a basis of sanction due to the late stage at which 
they were raised. See Robert Wayne Locklear, M.D., 85 FR 33738, 33745 
(2021). Accordingly, the OSC's specific substantive basis for proposing 
the denial of Registrant's registration application is his mandatory 
exclusion under 21 U.S.C. 824(a)(5).
    Prior Agency decisions have addressed whether it is appropriate to 
consider a provision of 21 U.S.C. 824(a) when determining whether or 
not to grant a practitioner registration application. For over forty-
five years, Agency decisions have concluded that it is. Robert Wayne 
Locklear, M.D., 86 FR 33744-45 (collecting cases); see also, William 
Ralph Kincaid, In the recent decision Robert Wayne Locklear, M.D., the 
former Acting Administrator stated his agreement with the results of 
these past decisions and reaffirmed that a provision of section 824 may 
be the basis for the denial of a practitioner registration application. 
86 FR 33745. He also clarified that allegations related to section 823 
remain relevant to the adjudication of a practitioner registration 
application when a provision of section 824 is involved. Id.
    Accordingly, when considering an application for a registration, I 
will consider any actionable allegations related to the grounds for 
denial of an application under 823 and will also consider any 
allegations that the applicant meets one of the five grounds for 
revocation or suspension of a registration under section 824. Id. See 
also Dinorah Drug Store, Inc., 61 FR 15972, 15973-74 (1996).
1. 21 U.S.C. 823(f): The Five Public Interest Factors
    Under Section 304 of the Controlled Substances Act, ``[a] 
registration . . . to . . . dispense a controlled substance . . . may 
be suspended or revoked by the Attorney General upon a finding that the 
registrant . . . has committed such acts as would render his 
registration under section 823 of this title inconsistent with the 
public interest as determined by such section.'' 21 U.S.C. 824(a)(4). 
In the case of a ``practitioner,'' defined in 21 U.S.C. 802(21) to 
include a ``physician,'' Congress directed the Attorney General to 
consider the following factors in making the public interest 
determination:
    (1) The recommendation of the appropriate State licensing board or 
professional disciplinary authority.
    (2) The applicant's experience in dispensing, or conducting 
research with respect to controlled substances.
    (3) The applicant's conviction record under Federal or State laws 
relating to the manufacture, distribution, or dispensing of controlled 
substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety. 21 U.S.C. 823(f).
    In this case, it is undisputed that Respondent holds a valid state 
medical license and is authorized to dispense controlled substances in 
the State of New York where he practices. RD, at 13; see also GX 1.
    Because the Government has not timely alleged that Respondent's 
registration is inconsistent with the public interest under section 
823, I will not deny Respondent's application based on section 823, and 
although I have considered 823, I will not analyze Respondent's 
application under the public interest factors. Therefore, in accordance 
with prior agency decisions, I will move to assess whether the 
Government has proven by substantial evidence that a ground for 
revocation

[[Page 59194]]

exists under 21 U.S.C. 824(a). Supra II.C.
2. 21 U.S.C. 824(a)(5): Mandatory Exclusion From Federal Health Care 
Programs Pursuant to 42 U.S.C. 1320a-7(a)
    Under Section 824(a) of the Controlled Substances Act (hereinafter, 
CSA), a registration ``may be suspended or revoked'' upon a finding of 
one or more of five grounds. 21 U.S.C. 824. The ground in 21 U.S.C. 
824(a)(5) requires that the registrant ``has been excluded (or directed 
to be excluded) from participation in a program pursuant to section 
1320a-7(a) of Title 42.'' Id. Here, there is no dispute in the record 
that Registrant is mandatorily excluded from federal health care 
programs under 42 U.S.C. 1320a-7(a). The Government has presented 
substantial evidence of Respondent's exclusion and the underlying 
criminal conviction that led to that exclusion, and Respondent has 
admitted to the same. GX 2, at 1; GX 4, at 3; Respondent's Post-Hearing 
Brief, at 2. Accordingly, I will sustain the Government's allegation 
that Respondent has been excluded from participation in a program 
pursuant to section 1320a-7(a) of Title 42 and find that the Government 
has established that a ground exists upon which a registration could be 
revoked pursuant to 21 U.S.C. 824(a)(5).\6\ Although the language of 21 
U.S.C. 824(a)(5) discusses suspension and revocation of a registration, 
for the reasons discussed above, it may also serve as the basis for the 
denial of a DEA registration application. Dinorah Drug Store, Inc., 61 
FR 15973 (interpreting 21 U.S.C. 824(a)(5) to serve as a basis for the 
denial of a registration because it ``makes little sense . . . to grant 
the application for registration, only to possibly turn around and 
propose to revoke or suspend that registration based on the 
registrant's exclusion from a Medicare program''). Respondent's 
exclusion from participation in a program under 42 U.S.C. 1320a-7(a), 
therefore, serves as an independent basis for denying his application 
for DEA registration. 21 U.S.C. 824(a)(5).
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    \6\ The Government correctly argues, and Respondent did not 
rebut, that the underlying conviction forming the basis for a 
registrant's mandatory exclusion from participation in federal 
health care programs need not involve controlled substances to 
provide the grounds for revocation or denial pursuant to section 
824(a)(5). Jeffrey Stein, M.D., 84 FR 46968, 46971-72 (2019); see 
also Narciso Reyes, M.D., 83 FR 61,678, 61,681 (2018); KK Pharmacy, 
64 FR 49507, 49510 (1999) (collecting cases); Melvin N. Seglin, 
M.D., 63 FR 70,431, 70,433 (1998); Stanley Dubin, D.D.S., 61 FR 
60727, 60728 (1996).
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    Here, there is no dispute in the record that Respondent is 
mandatorily excluded pursuant to Section 1320a-7(a) of Title 42 and, 
therefore, that a ground for the revocation or suspension of 
Registrant's registration exists. 21 U.S.C. 824(a)(5).
    Where, as here, the Government has met its prima facie burden of 
showing that a ground for revocation exists, the burden shifts to the 
Respondent to show why he can be entrusted with a registration. See 
Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019).

III. Sanction

    The Government has established grounds to deny a registration; 
therefore, I will review any evidence and argument the Respondent 
submitted to determine whether or not the Respondent has presented 
``sufficient mitigating evidence to assure the Administrator that [he] 
can be trusted with the responsibility carried by such a 
registration.'' Samuel S. Jackson, D.D.S., 72 FR 23848, 23853 (2007) 
(quoting Leo R. Miller, M.D., 53 FR 21931, 21932 (1988)). ```Moreover, 
because ``past performance is the best predictor of future 
performance,'' ALRA Labs, Inc. v. Drug Enf't Admin., 54 F.3d 450, 452 
(7th Cir. 1995), [the Agency] has repeatedly held that where a 
registrant has committed acts inconsistent with the public interest, 
the registrant must accept responsibility for [the registrant's] 
actions and demonstrate that [registrant] will not engage in future 
misconduct.''' Jayam Krishna-Iyer, 74 FR 459, 463 (2009) (quoting 
Medicine Shoppe, 73 FR 364, 387 (2008)); see also Samuel S. Jackson, 
D.D.S., 72 FR 23853; John H. Kennnedy, M.D., 71 FR 35705, 35709 (2006); 
Prince George Daniels, D.D.S., 60 FR 62884, 62887 (1995). The issue of 
trust is necessarily a fact-dependent determination based on the 
circumstances presented by the individual respondent; therefore, the 
Agency looks at factors, such as the acceptance of responsibility and 
the credibility of that acceptance as it relates to the probability of 
repeat violations or behavior and the nature of the misconduct that 
forms the basis for sanction, while also considering the Agency's 
interest in deterring similar acts. See Arvinder Singh, M.D., 81 FR 
8247, 8248 (2016).

A. Acceptance of Responsibility

    In evaluating the degree required of a respondent's acceptance of 
responsibility to entrust him with a registration, in Mohammed Asgar, 
M.D., the Agency looked for ``unequivocal acceptance of responsibility 
when a respondent has committed knowing or intentional misconduct.'' 83 
FR 29569, 29572 (2018) (citing Lon F. Alexander, M.D., 82 FR 49704, 
49728). Here, Respondent has not alleged that he committed the 
misconduct in question unknowingly or unintentionally. I will, 
therefore, look for a clear acceptance of responsibility from 
Respondent.
    Respondent is clearly remorseful for his conduct, testifying that 
it was ``the wrong thing to do'' and that he ``regret[s] it every day, 
to this day.'' Tr. 32. However, remorse and acceptance of 
responsibility are not the same thing, and I agree with the ALJ's 
conclusion that Respondent's consistent focus on his own suffering does 
not suggest an unequivocal acceptance of responsibility, but rather, 
suggests regret for the negative consequences that he has personally 
faced. RD, at 34. As the ALJ found, ``Respondent was more remorseful of 
the impact that his decisions had on his own life, rather than the 
effects his actions posed to his patients.'' Id. Additionally, I, too, 
am ``not convinced that [Respondent] would not take part in such a 
scheme in the future, if the monetary need were to arise.'' Id. at 36. 
Throughout his testimony, Respondent highlighted his own suffering 
above all else, emphasizing that he had ``destroyed [his] whole life'' 
and lamenting how he had ``embarrassed [himself], [his] family, [and] 
became an embarrassment to [his] patients, to [his] community, [and] to 
[his] church . . . .'' Tr. 47. Though Respondent did acknowledge that 
his actions had affected his patients, his testimony quickly shifted 
focus to what he had personally suffered, particularly that he had gone 
to prison ``away from [his] family, [and] [his] young children, for two 
years.'' Id. at 49. Even when Respondent stated that his actions were 
not ``a victimless crime'' and that ``[his] patients were the victims'' 
his explanation for why his patients were victims was that ``[t]hey 
lost [him], [he] lost them.'' \7\ Id. at 60. Further, according to 
Respondent's testimony, when Respondent spoke to

[[Page 59195]]

the Medical Society of Staten Island and to the resident physicians at 
the Richmond University Medical Center, he ``tried to deter them from 
it, not to make [the same] mistake because . . . [he] destroyed his 
whole life.'' Id. at 47.
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    \7\ I also find it troubling that Respondent has clearly not 
attempted to fully understand the impact of his actions on others. 
His na[iuml]ve belief that his patients were only victims because 
they lost him demonstrates that he has failed to even question 
whether there were greater impacts on his patients, potentially 
related to insurance claims or increases in pricing, or impacts on 
the laboratories that were legitimately conducting their business. I 
weigh Respondent's inability to perceive the full impact of his 
wrongdoing against a finding that Respondent has accepted 
responsibility. See Robert Wayne Locklear, M.D., 86 FR 33738, 33747 
(2021) (finding it ``significant in evaluating [the applicant's] 
acceptance of responsibility that he did not seem to be aware of the 
full extent of the harm that he caused.'').
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    Additionally, there are points of Respondent's testimony and 
actions in the record that suggest attempts to downplay his mistakes, 
further demonstrating a lack of clear acceptance of responsibility and 
a lack of full appreciation for the severity of his misconduct. As the 
ALJ found, I too find it particularly alarming that despite everything 
that has happened, Respondent testified at the hearing that BLS was a 
``credible laboratory, actually'' and did not clarify his 
characterization until later prompted to do so. Id. at 33, 53-55. I am 
also troubled by the letter that Respondent wrote to the Department of 
Health and Human Services in which, according to his testimony, he had 
questioned his ten-year exclusion and requested a decrease (which was 
ultimately rejected) because his misconduct had nothing to do with 
billing and ``all [he] did was [he] accepted the bribes.'' Id. at 51-
52. On direct examination, Respondent defended his characterization of 
BLS as a ``credible laboratory'' and claimed ``[t]hey never had any 
issues with performing the laboratory tests or [for] obtaining results. 
They were legitimate results, they were accurate results, and they were 
verified,\8\ as well. They never did any improper testing. Their 
turnaround time was quicker than the other laboratories, which was also 
another reason why [he] used them, as well.'' Id. at 33. As the ALJ 
noted, ``[Respondent's] consistent bolstering of [BLS's] credentials 
tends to serve as a validation of his behavior.'' RD, at 36. Regarding 
himself, Respondent emphasized that he never prescribed unnecessary 
medication, never performed any unnecessary tests, was never charged 
with performing any unnecessary tests, that the government did not lose 
any money because of him, and that the payments made to BLS were not 
any higher than they would be to another laboratory. Id. at 32-34. 
Overall, Respondent's focus on himself and his minimization of his 
wrongdoings suggests that he has not unequivocally accepted 
responsibility for his actions and the harm that he caused. See Stein, 
84 FR 46972 (finding that a registrant's attempts to minimize his 
misconduct weigh against a finding of unequivocal acceptance of 
responsibility).
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    \8\ As the ALJ noted, Respondent initially claimed that he 
verified all of the BLS lab results, but then conceded that he had 
not actually verified the results of every single patient he sent to 
BLS. Id. at 55-58.
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    Even if Respondent's acceptance of responsibility for his 
wrongdoing had been sufficient such that I would reach the matter of 
remedial measures, Respondent has not offered adequate remedial 
measures to assure me that I can entrust him with a registration. See 
Carol Hippenmeyer, M.D., 86 FR 33748, 33773 (2021). While in prison, he 
kept up with medical journals, has taken a wide variety of courses--
including over 200 hours in continuing medical educations courses (CME) 
\9\--has become a CPR instructor, has taken certifications in ``areas 
of medicine that [he wants] to practice,'' and after his release, he 
spoke to the Medical Society of Staten Island and to the residents at 
Richmond University Medical Center about his crime.\10\ Id. at 38-39, 
49, and 64. In concluding his testimony regarding his remediation 
efforts, Respondent said, ``[medicine is] the only thing I know how to 
do, it's the only thing I want to do, and it's my passion . . . I just 
want to get back to practicing medicine, and get back to society.'' Id. 
at 49. From Respondent's testimony, it seems that the purpose of his 
remediation efforts was not as much about righting his wrongs and 
deterring others from similar acts as it was about saving Respondent's 
career. In fact, he even admitted to as much when he stated that after 
his release from prison, he ``just became very proactive because [he] 
wanted [his] medical license.'' Id. at 47. Accordingly, I find that, 
again, Respondent's consistent focus on how his own life has been 
impacted by his misconduct does not suggest that he can be entrusted 
with a DEA registration.
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    \9\ Though Respondent testified to completing CME courses, he 
did not provide evidence to the record confirming the completion of 
the courses.
    \10\ I commend Respondent on his attempts to have a deterrent 
effect on his colleagues and community. In Martinho, the former 
Acting Administrator considered this type of engagement in 
determining that a respondent who had been excluded from federal 
healthcare programs for accepting similar kickbacks for laboratory 
referrals could be entrusted with a registration; however, the facts 
of Martinho are very distinct from the facts on the present record. 
Michele L. Martinho, M.D., 86 FR 24012, 24019 (2021). The respondent 
in that case had dedicated herself to self-described ``restorative 
justice'' well beyond what was required by her probation--engaging 
in sixty-nine speaking engagements, which were featured in major 
news outlets. Id. Although her misconduct occurred for a similar 
amount of time and money, HHS penalized her with the minimum 
timeframe for exclusion, she engaged in a methodological survey to 
verify for her own conscience that she did not increase her blood 
draws and did not overstate that survey's value, she admitted that 
the lab had created insurance problems for her patients and tried to 
correct it, and importantly, she also fully, sincerely and credibly 
accepted responsibility for her actions, such that the prosecutor at 
her criminal sentencing stated that she ```had demonstrated a level 
of contrition that has been unique among the many, many doctors that 
we've dealt with in this case.' '' Id.
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B. Specific and General Deterrence

    In addition to acceptance of responsibility, the Agency gives 
consideration to both specific and general deterrence when determining 
an appropriate sanction. Daniel A. Glick, D.D.S., 80 FR 74800, 74810 
(2015). Specific deterrence is the DEA's interest in ensuring that a 
registrant complies with the laws and regulations governing controlled 
substances in the future. Id. General deterrence concerns the DEA's 
responsibility to deter conduct similar to the proven allegations 
against the respondent for the protection of the public at large. Id. 
Where a respondent has committed a crime with no nexus to controlled 
substances, it is sometimes difficult to demonstrate that a sanction 
will have a useful deterrent effect. In this case, I believe a sanction 
of denial of the application would deter Respondent and the general 
registrant community from unethical behavior and deceit, particularly 
involving the acceptance of money for unlawful and unethical acts. It 
is not difficult to imagine, as the Agency has repeatedly encountered, 
this situation repeating itself in the context of receiving money for 
controlled substance prescriptions. ``Deterring such deceit and knowing 
criminal behavior both in Respondent and the general registrant 
community is relevant to ensuring compliance with the CSA.'' Ibrahim 
Al-Qawaqneh, D.D.S., 86 FR 10354, 10357 (2021).

C. Egregiousness

    The Agency also looks to the egregiousness and the extent of the 
misconduct as significant factors in determining the appropriate 
sanction. Garrett Howard Smith, M.D., 83 FR 18910 (collecting cases). 
In this case, Respondent knew that his arrangement with BLS was wrong 
but accepted the arrangement anyway and kept it going for a long period 
of time because, ``at that time, he was financially pressed.'' Tr. at 
54. The arrangement was a blatant kick back scheme involving 
substantial monetary payments.\11\ In addition, the

[[Page 59196]]

arrangement was both periodic and ongoing for multiple years, giving 
Respondent plenty of opportunity to correct course, but there is 
nothing in the record to indicate that he had any intention of ending 
the arrangement. After receiving 2 to 3 thousand dollars per month, Id. 
at 70, there must have been a point at which he was no longer 
``financially pressed,'' and yet he continued.
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    \11\ Also, I am concerned about repeat behavior in this case 
because the wrongdoing appears to be influenced by social 
interactions. The fact that Respondent was first approached about 
the bribes by a ``friend of [his and his brother's],'' Tr. 53, 
participated in the arrangement with his brother, and they all 
engaged in social activities together during which payments were 
received, does not inspire confidence that Respondent will take his 
responsibility to his patients and his ethical obligations seriously 
in the future.
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    Furthermore, the exclusion letter notes that HHS/OIG deemed 
Respondent's criminal misconduct egregious enough to warrant an 
exclusion period in excess of the statutory minimum. GX 2, at 2. The 
exclusion letter explains that HHS/OIG excluded Respondent for ten 
years instead of the statutory minimum of five years because (1) 
Respondent's misconduct caused or was intended to cause financial loss 
of more than $50,000 to a government agency or program; (2) Respondent 
committed the misconduct over a period of at least a year; and (3) 
Respondent's sentence included incarceration. Id. See Michael Jones, 
M.D., 86 FR 20728, 20732 (2021) (considering the length of the HHS 
exclusion in assessing egregiousness).

D. Letters of Support

    My final item of consideration is the collection of eighteen 
letters that Respondent submitted from patients, colleagues, friends, 
and family to demonstrate his high level of care as a physician and his 
commitment to the Hippocratic Oath. Respondent's Post-Hearing Brief, at 
3-4;RX 1. Although I find the letters to be sincere, they can only be 
of limited weight in this proceeding because of the limited ability to 
assess the credibility of the letters given their written form. See 
Michael S. Moore, M.D., 76 FR 45867, 45873 (2011) (evaluating the 
weight to be attached to letters provided by the respondent's hospital 
administrators and peers in light of the fact that the authors were not 
subjected to the rigors of cross examination). Furthermore, these 
letters were not written for the purposes of recommending that 
Respondent be granted a controlled substances registration and 
therefore offer little value in assessing the Respondent's suitability 
to discharge the duties of a DEA registrant. William Ralph Kinkaid, 
M.D., 86 FR 40636, 40641 (2021). Instead, Respondent's letters were 
used by his criminal defense counsel prior to his sentencing, with most 
of the letters dated back to 2017. RX 1;Tr. 41. Additionally, almost 
all of the letters are unsigned, four are undated, and none of the 
letters are addressed to anyone at DEA. RX 1. Finally, because 
Respondent has not demonstrated an unequivocal acceptance of 
responsibility, any value that the letters may have offered in 
evaluating my ability to trust Respondent with a DEA registration is 
nullified by the fact that he, himself, has not shown that he can be so 
entrusted. Kinkaid, M.D., 86 FR 40641.
    As discussed above, to receive a registration when grounds for 
denial exist, a respondent must convince the Administrator that his 
acceptance of responsibility is sufficiently credible to demonstrate 
that the misconduct will not occur and that he can be entrusted with a 
registration. Having reviewed the record in its entirety, I find that 
Respondent has not met this burden. Although Respondent expressed 
remorse and took some responsibility for his actions through his guilty 
plea and his efforts at remediation, his acceptance of responsibility 
was not unequivocal. Respondent's consistent focus on his own suffering 
and his minimization of his wrongdoings both raise concerns that he 
does not truly understand the severity of his misconduct. Further, 
Respondent's remediation efforts, though genuine, suggest to me that 
Respondent views the negative consequences he has faced as obstacles to 
overcome in restoring his career rather than the result of a serious 
lapse in ethics that calls for self-reflection. As such, I am not 
convinced that Respondent would not commit similar misconduct again in 
the future if he believed that it would not result in negative 
consequences, if he found himself in difficult financial times, or if 
he was persuaded by a friend or family member. Accordingly, I will 
order the denial of Respondent's application for a certificate of 
registration.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 823, I hereby order that the pending application for a 
Certificate of Registration, Control Number W19115227C, submitted by 
Nicholas P. Roussis, M.D., is denied. This Order is effective November 
26, 2021.

Anne Milgram,
Administrator.
[FR Doc. 2021-23263 Filed 10-25-21; 8:45 am]
BILLING CODE 4410-09-P